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Not guilty

WASHINGTON - An independent review of the FIAU disaster conducted by the Institute of Medicine of the National Academy of Sciences has absolved the drug's sponsors, Eli Lilly and Co. and Oclassen Pharmaceuticals, of any responsibility, and concluded that the incident was an "unavoidable tragedy." The IOM report also criticized the FDA's response, warning that it could seriously impede new drug development.

The review of FIAU (fialuridine) also led the IOM committee to recommend new safety and monitoring regimes that could change the way many clinical trials are conducted.

The five deaths associated with FIAU occurred in a Phase II trial in hepatitis

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